PDF-HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include a

Limitation of Use Should only be used for acute treatment periods up to two or three weeks 1DOSAGE AND ADMINISTRATION DESCRIPTIONCLINCIAL PHARMACOLOGY121. FULL PRESCRIBING INFORMATION: CONTENTS* INDICATIONS AND USAGE1.1Alzheimer --------------------------RECENT MAJOR CHANGES---------------------------- Boxed Warning 04/15 Indications and Usage (1.1) 04/15 Dosage and Administration (2.1, 2.2) 04/15 Warnings a NDA 22-288/S-003 Reference ID: 3151309 NDA 22-288/S-003 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is a histamine H receptor antagoni Adults and Children 30 kg (66 lbs) or more: 0.3 to 0.5 mg (0.3 to 0.5 mL) intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary (2.1) Children 30 5.1Hypersensitivity5.2Exogenous Ochronosis5.3Effects on Endocrine System5.4Cutaneous ReactionsADVERSE REACTIONSUSE IN SPECIFIC POPULATIONS8.1Pregnancy8.3NursingMothers8.4Pediatric Use8.5Geriatric Use1 WARNING: LOSS OF BONE MINERAL DENSITY Women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be __________________________________________________________________ FULL PRESCRIBING INFORMATION INDICATIONS AND USAGE Jakafi is indicated for treatment of patients with intermediate or high-risk FULL PRESCRIBING INFORMATION CONTENTS INDICATIONS AND USAGEDOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHSCONTRAINDICATIONSWARNINGS AND PRECAUTIONS5152Nephrotoxicity53Neuromuscular Disorders54Bron Dermatologic ToxicityTemporarily interruptPOTELIGEO for moderate or severe skin rashes Permanently discontinue POTELIGEO for lifethreatening rash 51InfusionReactionsTemporarily interruptfor any infusi BALVERSA2FULL PRESCRIBING INFORMATION INDICATIONS AND USAGEBALVERSA is indicated for the treatment of adult patients with locally advanced or chemotherapy including within 12 months of neoadjuvant treatment and adjust dosing as needed 22 51 constipation nausea and vomiting as needed 22 52 Peripheral Neuropathy Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed 2 VITROL naltrexone for extendedrelease injectable suspension for intramuscular useInitial US ApprovalRECENT MAJOR CHANGESDosage and Administration 22 03/2021Warnings and Precautions 51 03/2021INDICATIO WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of BOTOXand all botulinum toxin products may spread from the area of injection to produ Limitations of Use: Due to the possible association between malignancy and calcitoninsalmon use, the need for continued therapy should be reevaluated on a . -------------------------------DRUG INTER